FDA OKs Third Indication for BOTOX Cosmetic

OCTOBER 04, 2017
FDA officials have approved onabotulinumtoxinA (BOTOX Cosmetic, Allergan) for its third indication for the temporary improvement in the appearance of moderate-to-severe forehead lines associated with frontalis muscle activity in adults. OnabotulinumtoxinA is a prescription medication that works by injection into the muscles.

With this approval, onabotulinumtoxinA is the first and only neurotoxin indicated for 3 facial treatment areas in the United States. The FDA initially approved OnabotulinumtoxinA in 2002 for the temporary improvement of the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines) and received its second indication for severe crow’s feet lines in 2013.

The approval is based on data from 2 clinical trials that supported this indication for onabotulinumtoxinA. In the first study, 61% of participants met the primary endpoint, which was the reduction of the severity of forehead lines, compared with a placebo at day 30. Forty-six percent of study participants in the second trial met the primary endpoint. The researchers found similar response rates seen across 3 treatment cycles of onabotulinumtoxinA.

The most common adverse effects of onabotulinumtoxinA include discomfort or pain at the injection site, headache and eye problems, double vision, blurred vision, drooping eyelids and eyebrows, and swelling of the eyelids.

OnabotulinumtoxinA dosing units are not the same as, or comparable to, any other botulinum toxin product.

FDA approves BOTOX Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults [news release]. Dublin, Ireland. Allergan plc; October 3, 2017. allergan.com/News/News/Thomson-Reuters/FDA-Approves-BOTOX-Cosmetic-OnabotulinumtoxinA-for. Accessed October 3, 2017.